PrEP & Soccer: A Program for Pharmacy Chains to Increase PrEP Awareness and Access Among Men

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07263048
Status
Not Yet Recruiting

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Conditions

  • HIV Prevention
  • Latino Men Who Have Sex With Men
  • Pharmacy

Eligibility Criteria

Sex
MALE
Age
18 Years - 54 Years
Healthy Volunteers
Not accepted

Interventions

  • PrEP & Soccer PrEP Navigation — BEHAVIORAL
    Pharmacies assigned to this group will receive personalized PrEP navigation support provided by a PrEP Navigator following baseline assessment. Sessions may be brief (\~15 minutes) or longer depending on participant needs. The navigator supplies a pamphlet describing PrEP (how it works, payment options), and CVS-provided HIV services; discusses whether PrEP or another HIV prevention strategy is best for the participant; and, if PrEP is selected, provides a referral to a PrEP provider.
  • CVS Health brochure — BEHAVIORAL
    Standard health information delivered via brochure, no active navigation components. Content includes a brochure describing services offered by CVS Health and the MinuteClinic.

Study Details

This type 3 Hybrid Effectiveness-Implementation study will evaluate PrEP \& Soccer, a multicomponent and multilevel implementation strategy delivered by a pharmacy chain to increase PrEP knowledge and initial PrEP appointment attendance among men. Using mixed methods and implementation science approaches, this parallel cluster randomized controlled study will assess key implementation factors at CVS Health pharmacy locations assigned either to the PrEP \& Soccer intervention or to a general CVS Health service information-only control.

Key Dates

Start date
Jul 31, 2026
Status verified
Dec 2025
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PrEP & Soccer Intervention
    Pharmacies assigned to "PrEP \& Soccer" group will receive personalized PrEP navigation support from the PrEP Navigator.
  • Active Comparator: Standard of care (CVS standard health information)
    Pharmacies assigned to the control group will receive a brochure describing services offered by CVS Health and the MinuteClinic.

Primary Outcome Measure

Self-report attendance at first PrEP appointment [ Time Frame: Baseline, 3 months, and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Maria R Velazquez, MPA
[email protected]
305-243-1946
Mariano Kanamori, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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